Open-label V565 Target Engagement Study

An Open-label Exploratory Study in Patient Volunteers With Ulcerative Colitis (UC), to Investigate Lamina Propria Presence and Evidence of Biological Effect of the Oral Domain Antibody V565

The purpose of the study is to confirm that V565 enters inflamed tissue, binds to TNF and reduces inflammation after oral dosing to patients with IBD.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Biological: V565

Detailed Description

Single-site, open-label study in up to 6 patients treated for up to 7 days with sigmoidoscopy and biopsies before and after treatment period to determine biological activity.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, E1 1BB
    • The Royal London Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Established diagnosis of UC for 12 months or more
• Distal disease, accessible by flexible sigmoidoscopy
• Mild to moderate UC as defined as Mayo score between 3 - 10 with Mayo endoscopic sub score ≥1

Exclusion Criteria:

• A known hypersensitivity to any of the inactive ingredients of the study treatment
• A diagnosis of any IBD except UC
• Isolated proctitis
• Stool culture positive for C. difficile or other enteric infection
• Untreated tuberculosis (TB); positive QuantiFERON-TB Gold Test result (performed by Central Laboratory)
• Evidence of previous or present hepatitis B or C infection
• Known severe viral infection within six weeks prior to Visit 1
• Current use of topical mesalazine or anti-infectives for serious infection (or within 1 week)
• Anti-TNFα therapy other than the study drug
• Parenteral or enteral nutrition therapy
• Current use of any biologic agent
• Primary failure or secondary loss of response (LOR) to use of a TNFα inhibitor
• Contraindication to TNFα inhibitor
• Clinically significant abnormal laboratory test result at screening
• Taken an investigational drug within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: V565; V565 orally three times daily for up to 7 days	Biological: V565; Capsules for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction of phosphorylation in mucosal biopsies	After 7 days oral treatment
Presence of drug in mucosal biopsies	After 7 days oral treatment

Collaborators and Investigators

• Sponsor: VHsquared Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2017
• Primary Completion (Actual): October 24, 2017
• Study Completion (Actual): October 24, 2017

Study Registration Dates

• First Submitted: October 9, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 12, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: V56503

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No